Inovare

Braile Biomédica launches transapical valve

Washington, DC - Brazilian developers of the Inovare transapical aortic valve are encouraged by the early experience with the device despite a 50% two-year mortality rate.

Here at CRT 2012, the Cardiovascular Research Technologies conference, Dr Valter Lima (Hospital São Francisco, Porto Alegre, Brazil) presented data from 93 of the 150 or so patients who have been implanted with the Inovare transcatheter aortic valve, a bovine pericardium and cobalt-chromium valve developed by Braile Biomédica.

In this initial experience with the device, 93% of the procedures—all transapical implants—were successful. Success was defined as achieving a mean valve gradient under 20 mm Hg with aortic regurgitation less than a grade 2+. The average mean valve gradient for all the patients was reduced from 43 mm Hg to 11 mm Hg after one year.

There were three deaths within 30 days. Mortality was 17% at one year and 50% at two years for the 79 patients for whom data are available. Lima explained the relatively high mortality is due to the small sample size and the severe illness of the patients. "It's self-defensive to say, but I think they were 'too-sick' patients," he said. "But still, 17% at the end of 12 months I think is acceptable. And, of course we need more data."

Lima explained that 76% of the patients treated so far were considered at high risk for valve surgery while the rest were completely inoperable. Also, 10 of the procedures so far were "valve-in-valve" implants for stenotic or regurgitant prosthetic valves. The patients' average STS score was 31.

Based on these results, Inovare earned regulatory approval in Brazil in November. It is currently available only for transapical implants, with 22F as the smallest size. The company is also developing an 18F transfemoral version, Lima said./.../